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GMP

Out-Licensing

We provide out-licensing services for developed medicinal products in pharmaceutical forms listed below. For more detailed information contact us

Pharmaceutical analysis

  1. We provide quality control analysis according to Ph. Eur., USP and in-house methods and requirements for raw materials and finished products in the range of:
    1. Identification testing
    2. Assay determination
    3. Related substances/ degradation testing
    4. Preservatives analysis
    5. Dissolution and disintegration testing
    6. Franz diffusion cell tests
    7. Rheological study
    8. Aerodynamic particle size distribution (Next Generation Impactor)
    9. Water determination
    10. Melting point
    11. Stability testing according to ICH/EMA guidelines (controlled conditions 25°C / 60% RH, 30°C / 65% RH, 40°C / 75% RH)
    12. Photostability testing
    13. Impurity synthesis, isolation, identification and qualification (IR, NMR, MS)
  2. Analytical techniques:
    1. Mainly high-performance liquid chromatography (HPLC) and ultra high-performance LC (UHPLC) with UV/Vis (DAD), RI, Flu detection.
    2. UV/Vis spectrophotometry
  3. Analytical method: development, validation and transferWe specialize in analytical method developing, validation and transfer (including assay, related substances and dissolution testing methods). Validation of methods are established by laboratory studies which ensure that methods meet the requirements of intended analytical applications. All works are conducted according to ICH guidelines
    1. Q2 (R1) Validation of analytical procedures : text and methodology
    2. Q3A(R2) – Impurities in New Drug Substances
    3. Q3B(R2) – Impurities in New Drug Products

Developed and validated methods can be further transferred to customers laboratory. At every stage we provide suitable quality documentation.

We provide research and development (R&D) services in the field of pharmaceutical formulation.

  1. Offered R&D activities, concerning various dosage forms (listed in section below) include:
    1. Compatibility studies
    2. Formulation development
    3. Solubility studies
    4. Discriminatory power determination
    5. Manufacturing process development studies
  2. We provide contract manufacturing services of pilot or full scale batches of medicinal products including stages :
    1. Process transfer and adaptation
    2. Manufacturing of various solid-, semi solid- and liquid dosage forms
    3. Packing, including blister packaging and bottle filling
  3. Among manufacturing process activities we offer:
    1. Manufacturing process development
    2. Optimization of the manufacturing process
    3. Manufacturing process validation
    4. Troubleshooting
    5. Scale-up activities

Dosage forms and technologies

We provide manufacturing of various dosage forms, applying modern technologies.

  1. Solid dosage forms:
    1. Granules
    2. Powders
    3. Pellets
    4. Tablets
    5. Lozenges
    6. Capsules (hard)
  2. Semi-solid dosage forms:
    1. Ointments
    2. Gels
  3. Liquid dosage forms:
    1. Solutions
    2. Suspensions
    3. Syrups
    4. Ear, oral and nasal drops
  4. Technologies:
    1. Wet or dry granulation
    2. Spheronization
    3. Extrusion
    4. Coating
    5. Homogenization

Bioanalytical Services

We provide wide range of protein testing services (for custom assignments contact us here):

  1. Recombinant protein expression and purification
  2. Protein formulation development
  3. Protein aggregation assay development
  4. Stability tests in different matrixes
  5. Analytical assay development

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